ISO/TC 209/WG 11 - Assessment of suitability of equipment and materials for cleanrooms

ISO 14644-15:2017 provides requirements and guidelines for assessing the chemical airborne cleanliness of equipment and materials which are foreseen to be used in cleanrooms and associated controlled environments which are linked to the ISO standard for cleanliness classes by chemical concentration (see ISO 14644‑8). The following are outside the scope of ISO 14644-15:2017: - health and safety requirements; - compatibility with cleaning agents and techniques; - cleanability; - biocontamination; - specific requirements of equipment and materials for processes and products; - design details of equipment.

ISO 14644-14:2016 specifies a methodology to assess the suitability of equipment (e.g. machinery, measuring equipment, process equipment, components and tools) for use in cleanrooms and associated controlled environments, with respect to airborne particle cleanliness as specified in ISO 14644‑1. Particle sizes range from 0,1 µm to equal to or larger than 5 µm (given in ISO 14644‑1). NOTE Where regulatory agencies impose supplementary guidelines or restrictions, appropriate adaptation of the assessment methodology can be required. The following items are not covered by this ISO 14644-14:2016: - assessment of suitability with respect to biocontamination; - testing for suitability of decontamination agents and techniques; - cleanability of equipment and materials; - requirements on design of equipment and selection of materials; - physical properties of materials (e.g. electrostatic, thermal properties); - optimizing performance of equipment for specific process applications; - selection and use of statistical methods for testing; - protocols and requirements for local safety regulations.